scope:

This Part of IEC 60601 is intended to help a MANUFACTURER through the key decisions and steps to be taken to perform a detailed RISK MANAGEMENT and USABILITY ENGINEERING PROCESSES for MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM, hereafter referred to as MEE or MES, employing a DEGREE OF AUTONOMY (DOA).

This document provides a definition of DOA of MEE or MES and a MEDICAL ROBOT, and also provides guidance on:

- methodologies to perform the RISK MANAGEMENT PROCESS and USABILITY ENGINEERING for an MEE or MES with a DOA;

- considerations of BASIC SAFETY and ESSENTIAL PERFORMANCE for an MEE and MES with a DOA; and

- identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and

- distinguishing between MEDICAL ROBOTS, and other MEE and MES.

Unless specified otherwise, this document considers MEE and MES together.

The MANUFACTURER of an MEE or MES with a DOA is expected to design and manufacture an MEE or MES that fulfils its INTENDED USE and does not have unacceptable RISK throughout its LIFE-CYCLE.

This document provides guidance to help the MANUFACTURER in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES with DOA. The document is also intended as guidance for future standard writers.

There are no prerequisites to this document.